Trimel Pharmaceuticals Corporation

Trimel Pharmaceuticals Corporation

October 24, 2013 19:36 ET

Trimel Announces Update Regarding CompleoTRT™ FDA Review

TORONTO, ONTARIO--(Marketwired - Oct. 24, 2013) - Trimel Pharmaceuticals Corporation (TSX:TRL) today announced that the Company has received an information request from the United States Food and Drug Administration (the "FDA") including several questions in connection with the new drug application ("NDA") for CompleoTRT™ submitted on April 29, 2013. As part of its review of the NDA and following an internal FDA mid-cycle review meeting, the Company has been asked to clarify several points relating to the analysis of the dosing arms in the CompleoTRT™ Phase III study and the utilization of certain data from such dosing arms to support the proposed product label. In particular, the FDA has requested an explanation regarding the relative performance of those patients that commenced treatment using a twice-a-day dose and were titrated to a three-times-a-day dose in accordance with the Company's proposed titration scheme.

The Company is committed to its currently proposed NDA submission and is working with external experts to prepare and submit an appropriate response to the FDA expeditiously. However, it should be noted that the FDA has suggested that the Company may consider seeking approval for a product using only the three-times-a-day dose, but that certain review issues would have to be considered further.

The Company has not been advised of a delay in connection with the review of CompleoTRT™ by the FDA. There is a risk that these communications and any further consultations with the FDA may result in a delay in product approval. The Company remains committed to the commercialization of CompleoTRT™ and will continue to work with the FDA towards obtaining approval. However, there can be no assurances that the Company will not be required to make changes to the NDA for CompleoTRT™ (including to the proposed labelling or dosage protocol) or that additional clinical data will not be required, and there is no certainty that CompleoTRT™ will ultimately be approved.

In light of these communications, the Company expects that the timing for a commercial partnership for CompleoTRT™ is likely to be negatively impacted. The Company continues to work towards such a partnership transaction and will provide an update at the appropriate time.

About CompleoTRT™

Trimel's most advanced product candidate, CompleoTRT™, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT™ is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.

Subject to FDA approval, CompleoTRT™ is designed to be applied to the interior lateral wall of the nasal cavity, where internal studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the "no touch" targeted delivery to the nasal mucosa, CompleoTRT™ should avoid skin-to-skin transference to spouses or other family members, a health risk that led the FDA to issue a "black-box" warning in May 2009 for secondary transference for all topical testosterone gel preparations.

About Trimel

Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT™, a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA for regulatory approval in the United States. For more information, please visit

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the Company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the Company is subject to a number of risks and uncertainties, including that CompleoTRT™ may not be approved by the FDA or that any approval may be delayed, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our prospectus dated April 18, 2013 which is available at Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

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